Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2025-12-30 @ 8:59 PM
Study NCT ID:
NCT05449756
Status:
RECRUITING
Last Update Posted:
2023-12-11
First Post:
2022-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Follow-up Study With Children Who Participated in the TEMPO Study in Their First Year of Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 705}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2029-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-04', 'studyFirstSubmitDate': '2022-07-04', 'studyFirstSubmitQcDate': '2022-07-04', 'lastUpdatePostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Parent-reported symptoms of allergies and infections', 'timeFrame': '7.5 years', 'description': 'The occurrence of parent-reported - symptoms suggestive of allergies and infections'}, {'measure': 'Parent-reported use of medications and/or a medical device', 'timeFrame': '7.5 years', 'description': 'The occurrence of parent-reported - use of medications and/or a medical device to prevent or relieve symptoms suggestive of allergies and infections'}, {'measure': 'Parent-reported - hospitalisations and visits to the emergency room', 'timeFrame': '7.5 years', 'description': 'The occurrence of parent-reported - hospitalisations and visits to the emergency room for symptoms suggestive of allergies and infections'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Allergy', 'Infections']}, 'descriptionModule': {'briefSummary': 'This is a follow-up study of a randomised clinical trial, called TEMPO (a double-blind randomized clinical trial investigating infant formula and human breast milk consumption), in which infants participated in their first year of life. The investigators like to know if these children develop allergies or infections in childhood and whether their feeding pattern in infancy plays a role.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'TEMPO study subjects who completed the final (12 months) visit in the TEMPO study and consented to be approached for follow-up', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects are eligible to participate in the TEMPO Follow-Up study in case:\n* they completed the final (12 months) visit in the TEMPO study.\n* parents agree that their contact details will be shared with a third party for study purposes.\n* parents agree that data collected in the TEMPO study will be used in the TEMPO Follow-Up study.\n* parents provide written informed consent for participation in the TEMPO Follow-Up in accordance with local law.\n\nExclusion Criteria:\n\n* Parents who do not have a smartphone, tablet or personal computer with internet access.'}, 'identificationModule': {'nctId': 'NCT05449756', 'briefTitle': 'A Follow-up Study With Children Who Participated in the TEMPO Study in Their First Year of Life', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nutricia Research'}, 'officialTitle': 'A Virtual, Decentralised Observational Follow-up Study Investigating Feeding Patterns in Infancy and the Associated Parent-reported Allergic Manifestations, Allergies and Infections in Childhood.', 'orgStudyIdInfo': {'id': 'EBB18TA23570'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children who participated in randomised clinical trail, called TEMPO, in their first year of life', 'description': 'Children who participated in randomised clinical trail, called TEMPO, in their first year of life', 'interventionNames': ['Other: Self-administered questionnaires']}], 'interventions': [{'name': 'Self-administered questionnaires', 'type': 'OTHER', 'description': 'Three-monthly self-administered digital questionnaires (accessed on smartphone, tablet or computer)', 'armGroupLabels': ['Children who participated in randomised clinical trail, called TEMPO, in their first year of life']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6191 JW', 'city': 'Beek', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Vivienne van de Walle, Dr', 'role': 'CONTACT'}], 'facility': 'PreCare Trial & Recruitment', 'geoPoint': {'lat': 50.94083, 'lon': 5.79722}}], 'centralContacts': [{'name': 'Danone Nutricia Research Research', 'role': 'CONTACT', 'email': 'register.clinicalresearchnutricia@danone.com', 'phone': '+31 30 2095 000'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nutricia Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}